Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Kloxerate Plus Milking Cow is an off-white stable intramammary suspension prepared under sterile conditions. Each single dose 5 g syringe contains:

Ampicillin, as sodium salt	75 mg
Cloxacillin, as sodium salt	200 mg

Cloxacillin sodium and Ampicillin sodium are semi-synthetic penicillins derived from 6-aminopenicillanic acid.

Uses

Kloxerate Plus is specially formulated for the broad-spectrum treatment of clinical mastitis in the milking cow.

Kloxerate Plus is indicated for use against Gram-positive and Gram-negative bacteria associated with mastitis and susceptible to cloxacillin and ampicillin therapy. It is usually active against: Streptococcus agalactiae, Streptococcus dysgalactiae and other Streptococcal species; penicillin-resistant and penicillin-sensitive Staphylococci, Arcanobacterium pyogenes, E. coli and other Gram-negative bacteria.

Kloxerate Plus is bactericidal at the concentrations produced and is non-irritant in the udder tissue.

Dosage and administration

To be used under the guidance of a veterinary surgeon.

The contents of one syringe should be infused into each affected quarter via the teat canal, immediately after milking, at 12 hour intervals, for 3 consecutive milkings. Clean and disinfect the teat before each treatment.

Contra-indications, warnings, etc

Withdrawal Periods: Milk for human consumption must not be taken from a cow during treatment. With cows milked twice daily, milk for human consumption may only be taken from 60 hours (i.e. at the 5th milking) from the last treatment.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 4 days from the last treatment.

With other milking routines, the basis of the veterinary surgeon's advice should be that milk may be taken for human consumption only after the same period from the last treatment. (For example, with three times a day milking with the product administered twice per day, milk for human consumption may only be taken at the 8th milking).

Operator warnings

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure, taking all recommended precautions.

3. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C.

The syringe may only be used once. Part-used syringes must be discarded.

Keep out of the reach and sight of children.

Legal category

POM-V

Packaging Quantities

Packs of 24 single dose syringes.

Further information

Disposal:

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

Vm 01596/4089.